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Recruiting Phase 1 NCT05865470

NCT05865470 Age-dependent Effects of Smoked and Oral Delta-9-THC

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Clinical Trial Summary
NCT ID NCT05865470
Status Recruiting
Phase Phase 1
Sponsor University of California, Los Angeles
Condition Pain
Study Type INTERVENTIONAL
Enrollment 103 participants
Start Date 2025-04-30
Primary Completion 2028-10-15

Trial Parameters

Condition Pain
Sponsor University of California, Los Angeles
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 103
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-04-30
Completion 2028-10-15
Interventions
CannabisDronabinolSmoked Placebo

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Brief Summary

This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.

Eligibility Criteria

Inclusion Criteria: * Male or non-pregnant female aged 18-65 years according to the below criteria: EMERGING ADULTS: 18-25 years of age (+/- one year) MIDDLE-AGED ADULTS: 35-45 years of age (+/- one year) LATE MIDDLE-AGED ADULTS: 55-65 years of age (+/- one year) * Report weekly-monthly use of cannabis (with primary mode of use via inhalation) over the past 6 months prior to screening * Not currently seeking treatment for their cannabis use * No reported clinically significant adverse effects with cannabis use * Have a Body Mass Index from 18.5 - 34kg/m2 * Able to perform all study procedures * FEMALES: Currently practicing an effective form of birth control if pre-menopausal Exclusion Criteria: * Meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria for any substance use disorder other than nicotine and mild cannabis use disorder * Report using other illicit drugs in the prior 4 weeks * Evidence of severe psychiatric illness (e.g. mood disorder with function

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